Pantoprazole suppresses Helicobacter pylori without affecting cure

Background. Short-term, low-dose triple regimens composed of proton-pump inhibitors (PPI) and two antibiotics are the current gold standard therapy for cure of Helicobacter pylori infection. To date, the effect of PPI pretreatment on eradication outcome is not known. The aim of this study was to evaluate the influence of pretreatment with pantoprazole on the efficacy of an ensuing triple therapy.
Methods. In this open, randomized, monocenter, parallel group comparison, 107 patients with duodenal ulcer or functional dyspepsia were assigned to receive one of the following treatment regimens: a 7-day triple therapy with pantoprazole, 40 mg bid; clarithromycin, 250 mg bid; and metronidazole, 400 mg bid, which was either preceded or followed by a 7-day therapy with pantoprazole, 40 mg (P-PCM or PCM-P). Assessment of H. pylori status was performed by a biopsy urease test and ¹³C urea breath test at the initial visit and ¹³C urea breath test at all follow-up visits.
Results. The 7-day pantoprazole pretreatment resulted in a significant decline of the δ values of the ¹³C urea breath test. H. pylori infection was cured in 47 of 52 intention-to-treat patients of the P-PCM group (90%; 95% confidence interval, 79–97%) and in 46 of 53 of the PCM-P group (87%; 95% confidence interval, 75–95%).
Conclusions. Pretreatment with pantoprazole suppresses H. pylori but does not impair the efficacy of a consecutive short-term, low-dose triple therapy.     

Four-day, twice daily, quadruple therapy with amoxicillin, clarithromycin, tinidazole and omeprazole to cure Helicobacter pylori infection: a pilot study

Background. The best regimen for the treatment of Helicobacter pylori infection has yet to be defined. Four-day quadruple therapy with tetracycline, metronidazole, bismuth, and a proton pump inhibitor has been shown to obtain a very high cure rate. However, the fact that it must be taken four times daily may interfere with compliance. The objective of the study was to test the efficacy and tolerability of a new 4-day therapy with 4 drugs taken every 12 hours to cure H. pylori infection.
Patients and Methods. Fifty-six consecutive patients with peptic ulcer disease and H. pylori infection were treated with an oral 4-day course with omeprazole (20 mg/12 hours), clarithromycin (500 mg/12 hours), amoxicillin (1 g/12 hours) and tinidazole (500 mg/12 hours). Efficacy of the treatment was determined at least 2 months after therapy either by biopsy (in the case of gastric ulcer) or by ¹³C-urea breath test. A second breath test was performed at least 6 months after therapy.
Results. Two patients were lost to follow-up. Forty-nine of the remaining 54 patients were cured at the first control [intention-to-treat cure rate: 87.5% (CI 95% 75–94%); per protocol cure rate: 90.7% (CI 95% 81–98%)]. Forty-three of these 49 cured patients returned for a second ¹³C urea breath-test at 6–12 months. Two of them were not cured, giving a long-term cure rate of 85.5% per protocol and 73.2% by intention-to-treat. Compliance was good, although 25 patients had mild side effects.
Conclusion. This particular four-day therapy is well tolerated, easy to follow, and achieves an acceptably high cure rate.     

Effect of Smoking and Histological Gastritis Severity on the Rate of H. pylori Eradication with Omeprazole, Amoxicillin, and Clarithromycin

Background. The combination of omeprazole, amoxicillin, and clarithromycin is a common regimen against Helicobacter pylori. Several recent studies have shown that smoking, high intragastric acidity, and the degree of histological gastritis are associated with H. pylori eradication failure.
Materials and Methods. One hundred and thirty-seven H. pylori –positive patients were treated with a 1-week regimen composed of omeprazole, 20 mg once daily; amoxicillin, 500 mg; and clarithromycin, 200 mg thrice daily. Success of the treatment was evaluated by histology and the ¹³C-urea breath test at least 4 weeks after completion of therapy. Data about age, gender, alcohol intake, smoking habits, and previous proton pump inhibitor intake were collected in patient interviews. We evaluated fasting gastric pH and the degree of histological gastritis before eradication of H. pylori.
Results. The overall eradication of H. pylori at 4 weeks was successful in 98 of 137 patients (72%). On the multivariate analysis, a low grade of inflammation in the antrum ( p ≤ .01; 95% confidence interval [CI], 2.34–16.75), low grade of activity in the fundus ( p ≤ .05; 95% CI, 1.31–9.65), and smoking ( p ≤ .05; 95% CI, 1.27–6.82) were the significant independent factors predicting treatment failure.
Conclusions. These findings indicate that H. pylori eradication therapy with omeprazole, amoxicillin, and clarithromycin is less effective in patients who smoke and more effective in patients with high scores of antral inflammation and fundal activity at baseline biopsy.     

13C urea breath test with nondispersive isotope-selective infrared spectrometry: reproducibility and importance of the fasting status

Background. The ¹³C urea breath test (¹³C-UBT) is the most convenient method for diagnosing Helicobacter pylori infection noninvasively. Nondispersive isotope-selective infrared spectrometry (NDIRS) is an inexpensive and easy alternative to mass spectrometry. The objective of this study was to evaluate: (1) the reproducibility of the ¹³C-UBT as performed by using the NDIRS method; (2) the repeatability of bags analysis and the impact of delayed analysis; and (3) the need for fasting status for the ¹³C-UBT.
Methods. The ¹³C-UBT was performed with 75 mg urea labeled with ¹³C, with breath samples collected at times 0 and 30 minutes. Results are expressed as delta over baseline (0/00). Fifty-three patients underwent two successive ¹³C-UBTs with an interval of 48 to 72 hours. The 106 collected bags were randomly reanalyzed immediately or 72 hours later. In 26 volunteer subjects, the ¹³C-UBT was performed both in a fasting condition and after a nonstandardized meal. The reproducibility was assessed by the method of Bland and Altman.
Results. The mean of difference between two successive tests was 0.14 0/00 (standard deviation, 0.90), and the coefficient of repeatability was 1.80 (confidence interval, 95%). The difference between two successive analyses was always less than 2.2% of the initial value. The coefficient of variation between two successive tests for the influence of a meal was 11.24.
Conclusion. The ¹³C-UBT as performed by using NDIRS is reproducible, analyses can be delayed up to 72 hours, and the test must be performed in fasting conditions.     

Addition of metronidazole to rabeprazole-amoxicillin-clarithromycin regimen for Helicobacter pylori infection provides an excellent cure rate with five-day therapy

Background. New triple therapy for eradication of Helicobacter pylori based on a proton pump inhibitor (PPI) provides a cure rate of approximately 90% with few adverse effects. Recently, a PPI-based quadruple therapy, which consists of a PPI plus bismuth-based triple therapy for 7 days, has been studied, and a sufficient eradication rate has been achieved. However, a shorter duration results in improved compliance. In this study, newly developed short-term, simple twice-daily quadruple therapy consisting of rabeprazole, amoxicillin, clarithromycin, and metronidazole (RACM) was compared with a PPI-based triple-therapy regimen for eradication of H. pylori.
Patients and Methods. This study was designed as a randomized open, prospective single-center study. Of a total of 105 H. pylori –positive patients, 55 received the RACM regimen for 5 days (rabeprazole, 10 mg bid; amoxicillin, 750 mg bid; clarithromycin, 200 mg bid; and metronidazole, 250 mg bid), and 50 received the RAC regimen for 5 days (rabeprazole, 10 mg bid; amoxicillin, 750 mg bid; and clarithromycin, 200 mg bid). Cure of the infection was assessed by HpSA ( H. pylori stool antigen immunoassay) 1 month after completion of therapy.
Results. The rates of eradication of H. pylori by RACM versus RAC were 94.5% (95% CI, 85–99) versus 80.0% (95% CI, 66–90) by intention-to-treat analysis; 98.1% (95% CI, 90–100) versus 87.0% (95% CI, 74–95) by all-patients-treated analysis; and 98.1% (95% CI, 90–100) versus 86.7% (95% CI, 73–95) by per-protocol analysis. No major adverse effects were reported, and 98.0% of patients reported complete compliance.
Conclusions. The simple twice-daily and short-term quadruple regimen for only 5 days provided an excellent eradication rate. Compliance with the regimen was high, and serious adverse effects were few. Therefore, the RACM regimen can be considered as safe and effective.     

Urea Breath Test in Children: The United States Prospective, Multicenter Study

Background: The urea breath test (UBT) is generally considered the gold standard for the diagnosis of Helicobacter pylori infections in adults.
Goals: To investigate the utility and accuracy of urea breath testing in children from the United States.
Methods: Children scheduled to undergo upper gastrointestinal endoscopy for various clinical symptoms underwent a ¹³C-UBT using the US standard protocol for adults. Results were compared with rapid urease testing (RUT), culture, and histology. H. pylori positivity was defined according to the FDA, Division of Anti-Infective Drug Products criteria, i.e. positive culture and/or positive RUT and histology. H. pylori negativity was defined as all tests negative. Results were evaluated by delta over baseline (DOB) and urea hydrolysis rate (UHR).
Results: A total of 176 children from five centers were evaluated; 48 were infected. Compared to the defined standard, the results with the UBT based on delta over baseline (DOB) cut-off value (positive: ≥ 2.4‰) showed that the sensitivity and specificity of the UBT were 97.9% and 96.1%, respectively. Based on the UHR cut-off value (positive: ≥ 10.0 µg/min), the sensitivity and specificity were 95.8% and 99.2%. In young children (2- to 5-year olds), sensitivity and specificity of UHR method were higher than the DOB method (100% and 100% vs 100% and 82.4%, respectively).
Conclusion: The US standard ¹³C-UBT proved to be both simple and accurate for the diagnosis of H. pylori infections in children. The UHR method to calculate of ¹³C-UBT result provided excellent results for children of all ages.     

Twenty-Minute Fasting Version of the US 13C-Urea Breath Test for the Diagnosis of H. pylori Infection

Background. In large-scale multi-center clinical trials, the US ¹³C-urea breath test (UBT) has proven to have a sensitivity and specificity of approximately 95%. Ingestion of a meal to delay gastric emptying has advantages of increasing the level of signal as well as prolonging the duration of significantly increased ¹³C excretion, at the expense of requiring 40 to 60 minutes to complete the test. Our aim was to explore the utility of the ¹³C-UBT with a total duration of 30 minutes or less.
Methods. After a baseline breath sample was obtained, 125 mg of ¹³C-urea was given in 100 ml of water, and additional breath samples were taken after 20 and 30 minutes. The results of the UBT were compared to histological assessment, culture, and the rapid urease test. ¹³C-UBTs were carried out on normal volunteers who underwent gastroscopy during which six mucosal biopsies were taken. Three biopsies were for histological evaluation (Genta stain), two for culture, and one was for agar gel rapid urease testing. The UBT was conducted 2 to 3 days either before or after the endoscopic procedure.
Results. The cutoff value for a positive UBT was enrichment of 2.4Δ%₀ (delta over baseline). Of the 66 tests, 51%₀ were Helicobacter pylori -positive. There were no false positive UBTs and only two false negative UBTs at 20 minutes (sensitivity, 96%; specificity, 100%). At 30 minutes, one other UBT was false negative (gray zone of 2.36%₀.) (sensitivity, 94%; specificity, 100%).
Conclusion. These results suggest that omission of the meal and shortening the duration of the US ¹³C-UBT to 20 minutes still may maintain excellent specificity and sensitivity of the test.     

Eradication of H. pylori with pantoprazole, clarithromycin, and metronidazole in duodenal ulcer patients: a head-to-head comparison between two regimens of different duration

Background. The study was conducted to compare the efficacy and tolerability of two pantoprazole-based triple therapies of different length in the eradication of H. pylori.
Methods. In this double-blind, multicenter parallel group comparison, H. pylori -positive patients were randomly assigned to either the PCM-7 group (7 days of pantoprazole 40 mg bid, clarithromycin 500 mg bid, metronidazole 500 mg bid) or the PCM-14 m group (modified 14 day therapy of the same regimen with metronidazole only given for 10 days due to labeling reasons). H. pylori status was determined by urease test, histology, culture, and ¹³C-urea breath test. Treatment outcome was assessed 6 weeks after intake of the last study medication.
Results. The following eradication rates were achieved: for PCM-7 in the MITT population 83% (89/107), in the PP population 84% (81/97); for PCM-14 m in MITT 87% (92/106), in PP 88% (91/104). Ulcer healing rates were: for PCM-7 in MITT population 99% (106/107), in the PP population 99% (96/97); for PCM-14 m in MITT 99% (105/106), in PP 99% (103/104). Gastrointestinal symptoms and gastritis scores decreased in both treatment groups. Equivalence of treatment regimens could be proven for all populations. In total, 64 patients reported adverse events. Five serious adverse events occurred, all unrelated to the study medication.
Conclusion. The two pantoprazole-based triple therapies tested in this study are equally effective in H. pylori eradication, ulcer healing and relief from ulcer pain. It is concluded that 7 days of triple therapy are generally sufficient.     

Eradication of Helicobacter pylori Using One-week Triple Therapies Combining Omeprazole with Two Antimicrobials: The MACH I Study

Background. Eradication of Helicobacter pylori provides potential cure in the majority of patients with peptic ulcer disease, and eradication rates of more than 90% have been reported, using omeprazole in combination with two antimicrobials. The choice of antimicrobials, dose regimen and duration of treatment have varied between studies, however, and an optimal treatment still has to be established.
Materials and Methods. We conducted an international, randomized, double-blind, placebo-controlled study involving more than 100 patients in each of six treatment groups in 43 hospital gastrointestinal units in Canada, Germany, Ireland, Sweden, and the United Kingdom. Patients (n=787) with proved duodenal ulcer disease were randomized to treatment twice daily for 1 week with omeprazole, 20 mg (O), plus either placebo (P) or combinations of two of the following anti-microbials: amoxicillin, 1 gm (A), clarithromycin, 250 or 500 mg (C250, C500), or metronidazole, 400 mg (M). Eradication of H. pylori was evaluated by ¹³C-UBT, performed before and 4 weeks after treatment cessation.
Results. The eradication rates for the all-patients-treated analysis were 96%. OAC500; 95%, OMC250; 90%, OMC500; 84%, OAC250; 79%, OAM; and 1%, OP. OAC500 and OMC250 achieved eradication rates with lower 95% confidence interval limits exceeding 90%. All regimens were well-tolerated, 96% of patients complied with their dose regimen, and 2.3% of the patients discontinued treatment owing to adverse events.
Conclusions. Omeprazole triple therapies given twice daily for 1 week produce high eradication rates, are well-tolerated, and are associated with high patient compliance. The two most effective therapies were those combining omeprazole, 20 mg, with either amoxicillin, 1 gm, plus clarithromycin, 500 mg, or metronidazole, 400 mg, plus clarithromycin, 250 mg, all given twice daily.     

Anti-Helicobacter pylori activity of Lactobacillus delbrueckii subsp. bulgaricus strains: preliminary report

Aims:  To evaluate the activities of six Lactobacillus delbrueckii subsp. bulgaricus (LB) strains against 30 Helicobacter pylori strains by agar-well diffusion method.
Methods and Results:  LB cultures [4 × 10⁸–4 × 10⁹ CFU ml⁻¹) either were prepared in milk at their native pH, 3·8–5·0, or were adjusted to pH 6·4–7·7. At low and neutralized pH, LB strains inhibited the growth by 40–86·7% and 16·7–66·7% of H. pylori strains, respectively. LB activity was strain-dependent. At low and neutralized pH, one and five H. pylori strains, respectively, were not inhibited by any LB strain. LB2 and LB3, taken together, were active against most metronidazole and clarithromycin resistant strains.
Conclusions:  All LB strains inhibited a number of H. pylori strains, including also antibiotic resistant strains. LB activity was strain-dependent and better at low pH. At low pH values, the most active LB strains were LB1, LB2 and LB3, inhibiting 86·7% of H. pylori strains, while at neutralized pH values, the most active LB strains were LB2 and LB3, inhibiting 53·3 and 66·7% of H. pylori strains, respectively.
Significance and Impact of the Study:  LB could be utilized in the treatment or prophylaxis of H. pylori infection and warrants clinical investigations.     

Quadruple therapy is effective for eradicating Helicobacter pylori after failure of triple proton-pump inhibitor-based therapy: a detailed, prospective analysis of 21 consecutive cases

Background. Data regarding the effectiveness of second-line treatment of Helicobacter pylori infection are limited, especially if microbiological studies are considered.
Methods and Patients. We conducted a prospective, uncontrolled study of a consecutive series of 21 peptic ulcer patients with failure of 1-week lansoprazole, amoxicillin, and clarithromycin. H. pylori status was evaluated by urease test, histology, culture, and urea breath test. Susceptibility to amoxicillin, clarithromycin, and metronidazole was studied by E -test. Cure of infection was defined as negative results from endoscopy-based tests 1 month after treatment and negative results from a urea breath test at 2 months. Treatment consisted of a 1-week combination of lansoprazole (30 mg bid), tetracycline (500 mg qid), metronidazole (500 mg tid), and bismuth subcitrate (120 mg qid).
Results. H. pylori was resistant to metronidazole in three cases, to clarithromycin in three cases, and to both clarithromycin and metroinidazole in an additional three patients. No resistance to amoxicillin was found. Eradication was obtained in 20 cases (95.2% confidence interval [CI], 76.2–99.9). The only patient in whom infection was not eradicated harbored a metronidazole-resistant (minimum inhibitory concentration> 32 μg/ml) strain. No significant side effects were reported.
Conclusion. Quadruple therapy obtains a high eradication rate even in patients with clarithromycin- and metronidazole-resistant strains. Further randomized and controlled studies are warranted and are urgently needed.     

The Ideal Therapy Must Be Def ined in Each Geographical Area: Experience with a Quadruple Therapy in Spain

Background. Multiple therapeutic combinations have been tested to determine the optimal regimen(s) for Helicobacter pylori eradication, leading to very different results depending on the geographical area. Our goal was to evaluate the efficacy of a "quadruple" therapy with omeprazole, tetracycline, bismuth and metronidazole in our area.
Materials and Methods. We investigate 106 consecutive patients with active peptic ulcer disease (duodenal, gastric or both) and Helicobacter pylori infection. One-week therapy with omeprazole 20 mg b.i.d., tetracycline hydrochloride 500 mg q.i.d., colloidal bismuth subcitrate 120 mg q.i.d., and metronidazole 250 mg t.i.d was prescribed. Between the days 30 and 40 after treatment ended follow-up endoscopy was performed. Eradication was defined as both negative urease test and histology. Between days 90 and 360 a ¹³C urea breath test was performed in 100 patients.
Results. Of the 106 patients in the study, 91 had duodenal ulcer, 12 had gastric ulcer, and 3 had both. Side effects were observed in 25% of the cases. Eradication was achieved in 87.7% (93/106; CI 79.9–93.3). Healing was obtained in 95.2% (100/105; CI 89.2–98.4); 97.8% (CI 92.4–99.7) in those eradicated and 75% (CI 42.8–94.5) in non-eradicated ( p < .01).
Conclusions. Quadruple therapy with omeprazole, tetracycline, bismuth subcitrate and metronidazole achieves healing rates up to 95–100%. The 87.7% eradication rate obtained suggests that the regimen we used is a reasonable therapeutic alternative in our area.     

Factors affecting the validity of the 13C-urea breath test for in vivo determination of Helicobacter pylori infection status in a mouse model

Background. The mouse model using a human isolate of Helicobacter pylori is being widely accepted as an economical means of studying gastric infection. A noninvasive monitoring method would be useful for repeated testing to establish the time course of infection and the efficacy of treatments. In this study, we describe factors that affect interpretation of ¹³C urea breath test results for the assessment of H. pylori infection status in this model.
Materials and Methods. Female C57Bl/6 mice that underwent gavage with H. pylori or saline were breath-tested using 50 μg of ¹³C urea at intervals up to 2 months after inoculation. The generation of ¹³CO₂ (excess δ¹³CO₂) by infected mice was compared to that of uninfected controls. The effects of diet, fasting, and coprophagy on the reliability of the ¹³C urea breath test were quantitated.
Results. Both commercial and synthetic mouse diets exhibited marked in vitro urease activity. A minimum fasting time of 13 hours prior to breath testing significantly reduced this dietary contribution to excess δ¹³CO₂ values. The coprophagic tendency of the mice caused spuriously high excess δ¹³CO₂ counts in the breath of both control and H. pylori –infected mice.
Conclusions. Although the dietary contribution to spuriously high values of excess δ¹³CO₂ in mice breath-tested for H. pylori infection was reduced by fasting, the high nonspecific urease activity generated by coprophagy severely limited the reliability of the urea breath test in the assessment of H. pylori infection status.     

Triple Therapy with Lansoprazole, Clarithromycin, and Amoxicillin for the Cure of Helicobacter pylori Infection: A Short Report

Background Given the therapeutic potential of proton pump inhibitor-based triple therapy for successful cure of Helicobacter pylori infection, we evaluated the efficacy and safety of lansoprazole with clarithromycin and amoxicillin in an open-label, single-center study.
Materials and Methods. H. pylori -positive patients self-administered lansoprazole, 30 mg; clarithromycin, 500 mg; and amoxicillin, 1 gm bid for 14 days. Patients were assessed pretreatment, at which time the presence of H. pylori was documented by rapid urease test, culture, or histology, following study drug administration (week 2) for a brief evaluation only, and at least 4 weeks posttreatment (week 6), which included endoscopy with collection of biopsy specimens for culture and histology testing.
Results. Primary clarithromycin and metronidazole resistance were observed in 6% (2 of 30) and 43% (13 of 30) of study patients, respectively. One month after the end of therapy, H. pylori infection was cured in 23 of 25 patients (92%; 95% confidence interval, 74%-99%). The triple-therapy regimen was well-tolerated; 17% of patients (5 of 30) reported mild to moderate adverse effects during the treatment period.
Conclusion. A 2-week, triple-drug combination of lansoprazole, clarithromycin, and amoxicillin is highly effective for cure of H. pylori infection. Additionally, the triple-drug combination was well-tolerated by patients infected with H. pylori.     

The Influence of Helicobacter pylori Status on Circulating Levels of the Coagulation Factors Fibrinogen, von Willebrand Factor, Factor VII, and Factor VIII

Background. Helicobacter pylori (H. pylori) infection has been associated with an increased risk of developing ischemic heart disease (IHD). It has been suggested that a persisting low-grade acute phase response results from the chronic inflammation caused by H. pylori infection, which may give rise to increased circulating levels of certain coagulation factors.
Materials and Methods. One hundred three (53 male) nonconsecutive, randomly selected white subjects with symptoms of dyspepsia were recruited for study from an outpatient endoscopy clinic at Leeds General Infirmary. The presence of H. pylori was determined by histological and microbiological investigation, a rapid urease test, and a ¹³carbon urea breath test (¹³C-UBT). Fibrinogen was measured by the Clauss method, factor VIII:C (FVIII:C) and factor VII:C (FVII:C) were measured by clotting rate assays, and the von Willebrand factor (vWF) was determined by an enzyme-linked immunosorbent assay.
Results. No difference was found in levels of coagulation factors according to H. pylori status. Multiple regression models were used to account for the effect of covariates and H. pylori status on levels of FVII:C, FVIII:C, vWF, and fibrinogen, and again H. pylori status was not a significant determinant of levels of any of these coagulation factors. No difference occurred in full blood count, platelet count, white cell count, or plasma viscosity in individuals who were H. pylori -positive compared with those who were negative.
Conclusions. H. pylori infection is not associated with increased circulating levels of fibrinogen, FVII:C, vWF.Ag, or FVIII:C or hemorrheology in this patient group.     

Impact of Quadruple Regimen of Clarithromycin Added to Metronidazole-Containing Triple Therapy Against Helicobacter pylori Infection Following Clarithromycin-Containing Triple-Therapy Failure

Background: The establishment of an optimal second-line regimen for Helicobacter pylori infection is required. Although quadruple therapy should overcome resistance to either clarithromycin or metronidazole, the effects of a quadruple regimen in second-line therapy are unknown. This study aims to evaluate the efficacy of triple therapy composed of proton pump inhibitor/amoxicillin plus metronidazole with the combined additive effects of clarithromycin as a second-line quadruple therapy against H. pylori infection.
Materials and Methods: Participants were 104 patients in whom first-line therapy containing proton pump inhibitor-amoxicillin-clarithromycin failed. Before starting second-line therapy, patients underwent endoscopy to obtain H. pylori strain for antibiotic susceptibility tests. Patients were randomized to receive rabeprazole (10 mg), amoxicillin (750 mg), and metronidazole (250 mg), either with clarithromycin (200 mg; RAMC group) or without (RAM group); all treatments were administered twice daily for 7 days. H. pylori eradication was confirmed by ¹³C-urea breath tests performed 2 to 3 months post-therapy.
Results: As shown by intention-to-treat/per-protocol analyses, the cure rates for H. pylori infection were 88.5%/93.9% and 82.7%/84.3% for the RAMC and RAM groups. Although the study probably had an insufficient power to show a significant difference between the cure rates of the two regimens, the eradication rates showed a clear trend in favor of the RAMC group. There were no severe side-effects in any group.
Conclusions: In Japan, the RAMC regimen is thought to be a promising alternative strategy for second-line eradication of H. pylori infection.     

Meta-analysis: Four-Drug, Three-Antibiotic, Non-bismuth-Containing "Concomitant Therapy" Versus Triple Therapy for Helicobacter pylori Eradication

Background: Low success rates with triple therapy for Helicobacter pylori infections have prompted search for alternatives. In one, a proton-pump inhibitor (PPI) and amoxicillin was followed by the PPI plus clarithromycin and a nitroimidazole (sequential therapy); in another, these four drugs were given concomitantly (concomitant therapy).
Aim: To compare concomitant therapy with standard triple therapy for H. pylori infection.
Methods: By searching PubMed, EMBASE, the Cochrane Central Register of Controlled Trials and abstracts of major gastrointestinal meeting, two independent reviewers systemically identified randomized controlled trials (RCT) comparing concomitant quadruple to standard triple therapies as well as studies reporting eradication rates of concomitant quadruple therapy in treatment of H. pylori . Pooled eradication rates and odds ratios (OR) with 95% confidence intervals (CI) were calculated, and univariable metaregression analysis for all extracted variables was conducted.
Results: We identified nine studies (10 treatment arms) including five qualifying RCTs (576 subjects) comparing concomitant (293 subjects, duration 3 to 5 days) and triple therapy (283 subjects, duration 5 to 10 days) and four other studies evaluating concomitant therapy (478 subjects, duration 3 to 7 days). Pooled estimates of the five RCTs showed superiority of concomitant therapy over triple therapy; with intention-to-treat) pooled OR of 2.86 (95% CI: 1.73–4.73) and per-protocol (PP) pooled OR of 3.52 (95% CI: 1.95–6.38). Considering all 10 treatment arms, the ITT eradication rate was 89.7% (95% CI: 86.8–92.1%) and PP was 92.9% (95% CI: 90.2–94.8%).
Conclusion: Concomitant therapy appears to be an effective alternative to triple therapy and is less complex than sequential therapy.     

Factors that affect results of the 13C urea breath test in Japanese patients

Background. The ¹³C urea breath test (UBT) is considered to be the most accurate way of diagnosing Helicobacter pylori infection. Our objective was to investigate the accuracy of the UBT in Japanese patients and the association of UBT values with histological findings.
Materials and Methods. A total of 169 consecutive patients were studied by endoscopy with histology, by serology with IgG antibody and test serum pepsinogen (PG), and by UBT. The association between UBT values and histological findings and the PG I / II ratio were analyzed in H. pylori –positive patients.
Results. Of 169 Japanese patients, 135 were H. pylori –positive on both histology and serology analysis, 27 were H. pylori –negative on both histology and serology analysis, and 7 patients showed differing results. Using a cutoff value of 2.5‰, test sensitivity was 100%, while specificity was 96%. Among the 135 H. pylori –positive patients, a significant relation was observed between UBT value and H. pylori colonization density of the corpus and antrum, neutrophil activity of the antrum, atrophy, and intestinal metaplasia of the corpus in the H. pylori –positive patients. Also, UBT values correlated with the PG I /II ratio. In multivariate analysis, the PG I /II ratio was the most important factor related to UBT values (odds ration [OR], 4.99; 95% confidence interval, 1.60–15.55).
Conclusions. The UBT is an accurate method for detecting H. pylori infection in the Japanese population, which shows a high prevalence of atrophic gastritis. Values are affected by H. pylori infection and by the severity of atrophic gastritis.     

Seven-Day Triple Therapy with Lansoprazole, Clarithromycin, and Metronidazole for the Cure of Helicobacter pylori Infection: A Short Report

Background To refine our understanding of anti- Helicobacter pylori treatment regimens further, we evaluated the efficacy and safety of lansoprazole given in combination with clarithromycin and metronidazole for 7 days in an open-label, multicenter study.
Materials and Methods. H. pylori -positive patients self-administered lansoprazole, 30 mg; clarithromycin, 500 mg; and metronidazole, 500 mg bid for 7 days. Patients were assessed at pretreatment, at which time the presence of H. pylori was documented by rapid urease test or histology and culture, following study drug administration (week 1) for a brief evaluation only, and at least 4 weeks posttreatment (week 5), including endoscopy with collection of biopsy specimens for culture and histology testing.
Results. Of the 60 patients enrolled in the study, 59 had confirmed H. pylori infection, and 51 were included in an intent-to-treat analysis of efficacy. Primary metronidazole and clarithromycin resistance were observed in 84% and 8% of study patients, respectively. One month after the end of therapy, H. pylori infection was cured in 40 of 51 patients (78%); 95% confidence interval, 65%–89%). The triple-therapy regimen was well-tolerated, with only 2 patients (4%) requiring premature withdrawal from the study due to treatment-related adverse events. Taste perversion (15.0%) and diarrhea (11.7%) were the most frequently reported adverse events possibly or probably related to study medication during the treatment period.
Conclusion. Despite a high prevalence of metronidazole resistance, a 1-week, triple-drug combination of lansoprazole, clarithromycin, and metronidazole is effective treatment for and well-tolerated by patients with H. pylori infection.